Effect of Add-on Montelukast to Inhaled Corticosteroids on Airway Responsiveness (SINGDEN)

June 3, 2009 updated by: Hvidovre University Hospital

Effect of Add-on Montelukast to Inhaled Corticosteroids in Excessive Airway Narrowing in Adults With Asthma

Leukotriene receptor antagonists appear to posses additive anti-inflammatory effects to the effect of inhaled corticosteroids.

Hypothesis: Treatment with oral montelukast will lower the dose-response plateau to inhaled methacholine in patients with mild to moderate persistent asthma treated with a stable dose of inhaled corticosteroids.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non-smoking adults with mild to moderate persistent asthma:

    • FEV1 > 70 % pred
    • PD20 methacholine < 3.9 mmol
    • treated for at least 3 months with a stable dose of inhaled corticosteroids
  • Documented dose-response plateau to inhaled methacholine on two occasions
  • Males and non-pregnant females

Exclusion Criteria:

  • Asthma medication other than inhaled corticosteroids and inhaled b2-agonists
  • Viral respiratory tract infections within the 3 weeks prior to enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Montelukast
Oral montelukast 10 mg once daily for 12 weeks
Drug: Montelukast (Singulair)
10 mg tablet once daily
Other Names:
  • Singulair
Placebo Comparator: Placebo
Oral placebo once daily for 12 weeks
Drug: Placebo
Oral placebo once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes from baseline in maximal FEV1 decline at the dose-response plateau
Time Frame: After 12 weeks of treatment
After 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes from baseline in PD20 methacholine
Time Frame: After 12 weeks of treatment
After 12 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Investigators

  • Principal Investigator: Zuzana Diamant, MD, PhD, Erasmus Medical Center
  • Principal Investigator: Charlotte S Ulrik, MD, DMSc, Dept. of Heart and Lung Diseases, Hvidovre Hospital, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

June 3, 2009

First Submitted That Met QC Criteria

June 3, 2009

First Posted (Estimate)

June 4, 2009

Study Record Updates

Last Update Posted (Estimate)

June 4, 2009

Last Update Submitted That Met QC Criteria

June 3, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SINGDEN-04-2002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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